Pipeline Review Check

On Jun 7, 2022 Vittoria Biotherapeutics reported it spun out of a University of Pennsylvania research lab is emerging from stealth mode with nearly $10 million from a seed funding round (Company Pipeline, viTToria biotherapeutics, FEB 10, 2023, View Source [SID1234627036]).

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Vittoria Biotherapeutics’ mission is to overcome current limitations of chimeric antigen receptor (CAR) T-cell therapeutics by using its unique cell engineering and gene editing technologies to create new therapies that address unmet clinical needs.

The technology the company is attempting to commercialize was developed by Dr. Marco Ruella, a hematologist from Italy who came to the United States 10 years ago to study under Penn CAR T-cell pioneers Dr. Carl June and Saar Gill.

Ruella, Vittoria’s scientific founder, is an assistant professor of medicine at the Center for Cellular Immunotherapies at Penn’s Perelman School of Medicine. He is also scientific director of the lymphoma program at the Hospital of the University of Pennsylvania.

Ruella said he got the idea to start a company about a year ago to further develop his method of augmenting CAR T-cell therapy with gene editing.

"I was very confident with my science, but not comfortable at all about what my next steps should be," Ruella said.

Gill, co-director of cell therapy and transplantation at Penn, co-founded two local cell and gene therapy companies: Carisma Therapeutics and Interius Biotherapeutics. He recommended Ruella talk with Bruce Peacock, a longtime life sciences industry entrepreneur and investor who was CEO at Adolor and Orthovita, held senior positions at Centocor and Cephalon, and is an investor and director at Carisma and Interius.

"Marco could see what he had and realized he needed a company to translate what he had accomplished into a meaningful therapy," Peacock said.

Peacock knew just the person to lead such a startup.

Prior to the company’s sale, Peacock was a major investor and board member at Invisible Sentinel, a Philadelphia life sciences company that had developed DNA contamination detection tools for the food, beer and wine industries. He knew its CEO, Nicholas Siciliano, was looking for his next challenge after Invisible Sentinel, where Siciliano is still a consultant, was acquired by bioMerieux of France for $75 million in 2019.

The trio — Ruella, Peacock and Siciliano — ended up co-founding the company, with Siciliano taking the CEO role and Peacock serving as board chairman.

"We fell in love with Marco and the science," Siciliano said. "The stars aligned."

The University of California and Foundery Sign Master Agreement to Translate Novel Discoveries into Transformational Immunotherapies

On February 9, 2023 The University of California, San Francisco ("UCSF") and Foundery, a biotechnology venture studio focused on translating immunology discoveries into drug candidates, reported the signing of a five-year master agreement to collaborate on the translation of scientific discoveries in immunology by UCSF scientists into drug development candidates to treat diseases caused by immune system dysfunction (Press release, Foundery Biosciences, FEB 9, 2023, View Source [SID1234656473]). The partnership is designed to support UCSF investigator research and create opportunities to develop and commercialize immunotherapeutics. Selected researchers will have access to Foundery’s preclinical drug discovery infrastructure.

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The master agreement is structured to enable UCSF researchers to propose candidate drug targets or compelling biology relevant to the identification, prevention, treatment or amelioration of human diseases with underlying immune dysfunction. Foundery’s team of highly experienced and accomplished scientists subsequently conduct translational research on prioritized candidate targets in Foundery’s internal laboratories. If the research results in a candidate molecule or platform with therapeutic potential, Foundery aims to transition the preclinical candidate either directly via sale to biopharmaceutical partners or through the creation of a financing syndicate with later-stage venture capital funds to further develop the program. The master agreement is designed to enhance collaboration and develop impactful therapeutics between UCSF, participating scientists, and Foundery.

"UCSF has launched a series of innovation advancement programs under our Innovation Ventures department, including grants, technology management, entrepreneurship guidance, and external partnerships, to address what the pharmaceutical industry refers to as the ‘therapeutic valley of death," said Peter Kotsonis, PhD, Interim Vice Chancellor of UCSF Innovation Ventures. "A solution to this problem has been challenging because researchers working in academic institutions often cannot easily access resources and expertise needed to advance their scientific discoveries beyond novel, largely untested concepts. UCSF’s programs are designed to support the institution’s research community with the intent of advancing their discoveries from concept to commercial therapies where the patients who will benefit most from new medicines can access them."

"UCSF’s newest strategic partnership with Foundery is very exciting," said Amy Gryshuk, PhD, Associate Director, Strategic Alliances, UCSF Innovation Ventures. "This aims to remove translational barriers for innovative UCSF investigators and provide them with the ability to translate their cutting-edge research into first-in-class immunotherapies."

Foundery is the latest drug-development endeavor established by Max Krummel, PhD, Chair of the UCSF Bakar ImmunoX Initiative, a program to facilitate sharing of technology and findings across fields, disciplines, and geographies. Dr. Krummel previously discovered, patented, and developed anti-CTLA-4 checkpoint blockade therapies as a graduate student and subsequently founded Pionyr Immunotherapeutics ("Pionyr") in 2016 to develop "Myeloid Tuning" approaches. He is joined by former Pionyr colleagues, Michel Streuli, PhD, and Venkataraman Sriram, PhD, Foundery’s Chief Executive Officer and Chief Scientific Officer, respectively, who helped advance three myeloid tuning programs from target concepts to IND-ready assets prior to Pionyr’s $1.5B acquisition by Gilead in 2020. Both Dr. Streuli and Dr. Sriram were also involved in the early development of an anti-PD1 antibody, now known as the blockbuster drug pembrolizumab (Keytruda).

"Foundery’s strategy is to partner both scientifically and financially with top-tier scientists in immunology to evaluate their discoveries for translational potential into future first- or best-in-class therapeutics," said Dr. Krummel. "Basic research scientists do not always have the time, resources or inclination to conduct translational research in their own laboratories. Our goal is to efficiently and expertly fill that gap. We are looking forward to a highly productive relationship with UCSF and to develop similar relationships with other major life science research institutions."

The Foundery team will operate laboratories at 350 Parnassus Avenue in San Francisco. The selected location provides unprecedented proximity to UCSF-based investigators and allows them to tap into Foundery’s seasoned preclinical drug discovery and development team and access proprietary platforms, assays, industry-qualified reagents, and top-tier CROs. Together, Foundery and UCSF will extend novel and untapped fundamental biological observations, create proof-of-concept data, and generate pharma-ready development candidate packages to more efficiently validate and translate early drug concepts into transformative therapies for immune-based diseases.

"We are not only scientific partners but investment partners as well," said Dr. Streuli. "UCSF and partnering scientists become de facto limited partners in the fund that is supporting the translational research. They receive financial rewards if our work on their programs is successful and also benefit from the overall success of Foundery’s portfolio. We believe that this arrangement is highly beneficial to all parties."

Financial Statement Release 2022

On February 9, 2023 Orion reported its financial statement 2022 (Press release, Orion, FEB 9, 2023, View Source [SID1234632998]).

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Full year and Q4 2022 results

On February 9, 2023 AstraZeneca reported its full year and Q4 2022 financial results (Press release, AstraZeneca, FEB 9, 2023, View Source [SID1234627085]).

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Hepion Pharmaceuticals to Ring the NASDAQ Stock Market Closing Bell on February 10, 2023

On February 9, 2023 Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical stage biopharmaceutical company focused on Artificial Intelligence ("AI")-driven therapeutic drug development for the treatment of non-alcoholic steatohepatitis ("NASH"), fibrotic diseases, hepatocellular carcinoma ("HCC"), and other chronic diseases, reported that its CEO, Robert Foster, PharmD, PhD, will lead it in ringing the Nasdaq Closing Bell on Friday, February 10, 2023 (Press release, Hepion Pharmaceuticals, FEB 9, 2023, View Source [SID1234627072]).

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The Closing Bell ceremony will be broadcast live starting at 3:45 p.m. Eastern Time from the Nasdaq MarketSite Tower in New York City. To view the broadcast, please visit www.nasdaq.com/marketsite/bell-ringing-ceremony or www.Facebook.com/Nasdaq.